Treatment of Mild or Moderate Melasma in Darker Skin with a 4% Hydroquinone Skin Care System Plus 0.025% Tretinoin Cream

Poster 4581 Treatment of Mild or Moderate Melasma in Darker Skin with a 4% Hydroquinone Skin Care System Plus 0.025% Tretinoin Cream Pearl Grimes, MD...
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Poster 4581

Treatment of Mild or Moderate Melasma in Darker Skin with a 4% Hydroquinone Skin Care System Plus 0.025% Tretinoin Cream Pearl Grimes, MD

JoAnne Watson, DPM

Vitiligo and Pigmentation Institute of Southern California Los Angeles, CA

OMP, Inc. Long Beach, CA

Funded by OMP, Inc.

Conflicts of Interest •

Dr Grimes – investigator and consultant for OMP, Inc.



Dr Watson – employee of, and holds stock and stock options in, OMP, Inc.

Purpose • To evaluate the efficacy and tolerability of treating melasma in darker skin using a 4% hydroquinone skin care system plus 0.025% tretinoin cream [This regimen treats melasma and provides a complete skin care routine]

Rationale for Study • Melasma can cause great distress with significant negative effects on a patient’s: – Emotional well being – Social life – Quality of life

• It is NOT merely a cosmetic nuisance ̶ such misperceptions have resulted in underdiagnosis and undertreatment • Hydroquinone and tretinoin are both effective in treating melasma and their use: – In combination facilitates faster improvements – As part of a comprehensive skin care system may offer additional advantages in terms of convenience, efficacy, and tolerability

• Optimal tolerability is especially important in darker skin to minimize the potential for other pigmentary problems

Inclusion Criteria • 25- to 65-year old females with: – Mild or moderate epidermal melasma (covering 11% to 40% of face), confirmed by Wood’s lamp examination – Minimal to marked intensity of melasma pigmentation – Cutaneous melanosis stable over preceding 3 months – Fitzpatrick skin type III-VI

Study Design • Patients used a 4% hydroquinone skin care system + tretinoin 0.025% cream on their face every day for up to 24 weeks (initial 12 weeks + optional 12-week extension)

Components of 4% Hydroquinone Skin Care System Component

Key Ingredients

Potential Effect

Foaming gel cleanser

Aloe barbadensis Soothing and anti-inflammatory activity leaf juice

Toner

Aloe barbadensis Soothing and anti-inflammatory activity leaf juice + Scavenging activity against active oxygen witch hazel Suppression of UV-induced erythema

4% hydroquinone

Hydroquinone

Reduction in pigmentation

Exfoliation enhancer

Glycolic acid + lactic acid

Exfoliation

Sunscreen SPF 35

Zinc oxide + octinoxate

Physical + chemical sunscreen

Treatment Regimen 4% hydroquinone skin care system, consisting of 6 proprietary products: 1. 2. 3.

Foaming gel cleanser (contains aloe barbadensis leaf juice) Toner (contains aloe barbadensis leaf juice and witch hazel) 4% hydroquinone

Twice daily

4. 5.

Exfoliation enhancer (contains glycolic acid and lactic acid) Sunscreen SPF 35

Each morning

6.

4% hydroquinone (different formulation to above) Each evening

0.025% tretinoin cream Plus, as needed: Moisturizer for dryness 0.5% hydrocortisone for other tolerability issues

Potential Advantages of Treatment Systems • Convenient – Provide medical treatment and overall skin care in one regimen, saving confusion juggling different regimens

• Popular with patients1 • May enhance compliance1 • May enhance efficacy: – Cleansing and exfoliating may help penetration of other ingredients into skin – Sunscreen may help maintain efficacy of treatment

• May enhance tolerability: – May contain agents with soothing and anti-inflammatory properties (eg, aloe barbadensis leaf juice and witch hazel) 1 Bowe

et al. Semin Cutan Med Surg 2008

Investigator Evaluations • • • • •

Melasma severity Pigmentation intensity Melasma area and severity index (MASI) Melasma improvement Erythema, dryness, peeling

Patient Evaluations • Improvement in photodamage-related parameters: – – – –

Skin texture/roughness Skin firmness Brown spots/discoloration Fine lines and wrinkles

• Quality of life: – – – – –

• • • •

Embarrassment/self-consciousness due to skin Focus by others on skin discoloration Feeling unattractive due to skin Effort put into hiding skin discoloration Social/leisure activities affected by skin

Effectiveness of treatment compared with other medications Satisfaction with effectiveness of treatment Ease of application Burning/stinging

Results • 20 females enrolled: – 100% (20/20) completed initial 12-week study – 90% (18/20) completed extension study to 24 weeks – 2 discontinued due to voluntary withdrawal

• Mean of 50 years old • 65% black/African American + 35% white/Caucasian • Fitzpatrick skin type: – IV (40%) – V (40%) – VI (20%)

• Melasma was: – Malar in 65% – Centrofacial in 35%

Melasma Severity 5

Moderate

4

Moderate

Median grade for melasma severity 3

**

***

Mild

*** ***

2 Scale 0 None (0) Minimal/trace (1) Mild (2 or 3) Moderate (4 or 5) Marked (6 or 7) Severe (8)

4

8

12

18

** 24

Mild

Week ** P≤.01, *** P≤.001 versus baseline

Pigmentation Intensity 5

Moderate

4

Moderate

3

Mild

Median grade for pigmentation intensity

Scale 2 None (0) 0 Minimal (1) Mild (2 or 3) Moderate (4 or 5) Marked (6 or 7) Severe (8)

***

4

***

8

***

12

***

18

***

24

Mild

Week *** P≤.001 versus baseline

MASI Score (Melasma Area and Severity Index) 12 11 10

Median MASI score

9 8

***

7 6

***

5

***

***

***

18

24

4

0

4

8

12

Week *** P≤.001 versus baseline

Improvement in Melasma 100 80% 75% 70% 67%

80 Patients (%)

85% 85% 75% 78% 74%

70%72% 60%

60 47%

40%

40 20 0

16%

Week: 4

8 12 18 24

At least 1-grade improvement in melasma severity

4

8 12 18 24

At least 1-grade improvement in melasma pigmentation intensity

4

8 12 18 24

Marked (≥ 51%) improvement in melasma

Patient-Reported Improvements in Photodamage-Related Parameters at Week 24 100 80 Patients with rating of good, very good, 60 or excellent improvement (%) 40

20

76% 69% Good Very good Very good

65%

Very good

59% Good

Very good Excellent

Excellent Excellent

0

Excellent

Skin texture/ roughness

Skin firmness

Brown spots/ discoloration

Fine lines and wrinkles

Improvement in Quality of Life Parameters Baseline

Week 4

100 80 Patients rating parameter as “very much” or “a lot” (%)

Week 24

90% 80%

80%

58%

60 47%

40 20

Week 12

20% 18%

42% 35%

37% 35%

55% 37% 15% 12%

18%

50% 42% 20% 18%

0 Embarrassed/ self-conscious due to skin

Feeling unattractive due to skin

Effort put into hiding skin discoloration

Focus on skin discoloration by others

Social/leisure activities affected

Patient Ratings at Week 24 100 80

Patients (%)

75% More effective

80%

81%

Satisfied

Easy

Very satisfied

Very easy

60 40

Much more effective

20 0

Study treatment more effective than other medications

Satisfied with overall effectiveness of treatment

Study treatment easy to apply

Improvement in Melasma

BASELINE

WEEK 12

BASELINE

BASELINE

WEEK 12

WEEK 12

Improvement in Melasma

BASELINE

BASELINE

WEEK 12

WEEK 12

BASELINE

WEEK 12

Efficacy Summary • Treating melasma with the 4% hydroquinone skin care system + 0.025% tretinoin was associated with: – Significant improvements in melasma • Less severe melasma (P≤.01 from week 4 onward) • Less intense pigmentation (P≤.001 from week 4 onward) • Lower MASI score (P≤.001 from week 4 onward)

– High levels of patient satisfaction – Considerable improvements in quality of life • • • • •

Less embarrassment/self-consciousness Less feeling of being unattractive Less effort hiding skin discoloration Less focus from other people on the melasma Less effect on social and leisure activities

– Good improvements in photodamage-related parameters: • • • •

Skin texture Skin firmness Brown spots/discoloration Fine lines and wrinkles

Adverse Events • 4 patients had adverse events at least probably related to treatment: – Erythema – Erythema/dryness – Dryness/peeling – Erythema/dryness/stinging sensation

• All were mild except erythema was moderate in 1 patient

Tolerability • Erythema, dryness, peeling, and burning/stinging (evaluated up to week 12 only): – Mean grades between “none” and “trace” at all timepoints – Median grades “none” at all timepoints – Only significant change from baseline was ↑ erythema at week 12

• 17/20 (85%) patients used the study moisturizer: – 0 as treatment for dryness – 17 as preventive measure

• 3/20 (15%) patients used hydrocortisone: – 1 for erythema/stinging sensation – 3 as preventive measure

Conclusion • Using the 4% hydroquinone skin care system + 0.025% tretinoin cream to treat epidermal melasma in darker skin can achieve significant reductions in: – Melasma severity – Melasma pigmentation intensity – Melasma area and severity index • Importantly, treatment is also associated with considerable improvements in: – Quality of life – Signs of photodamage (eg, skin roughness, fine lines/wrinkles) • Treatment is well tolerated and associated with a high level of patient satisfaction

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